WARNINGS

PRECAUTIONS

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy: Teratogenic Effects Category C.

Animal reproduction studies have not been conducted with nystatin (nystatin (oral)) oral suspension. It is also not known whether nystatin (nystatin (oral)) oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin (nystatin (oral)) oral suspension should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether nystatin (nystatin (oral)) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin (nystatin (oral)) is administered to a nursing woman.